Sdlc Compliance Ltd

SDLC Compliance is specialist software regulatory and compliance consulting company focused on regulated Digital Health, medical device software and software as a medical device (SaMD). Our goal is to help you through the complex compliance and regulatory processes so you can get the appropriate approvals and registrations for your health product and release to market faster. We can help you with creating a lean and compliant quality and compliance processes and procedures, compliant to ISO standards and FDA requirements, so you can obtain the appropriate certification and approvals from regulatory agencies. Our Services- Software life cycle audit, compliance Gap Analysis, and implementation roadmap - Quality procedures and templates to meet all ISO standards (ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 62366) and relevant FDA regulations and guidance- Help you understand key standards, technical information reports, and guidance for software in the medical device industry - How to write compliant and lean software requirements, architecture and detailed design documents- Software safety classification - Software development, testing (V&V), maintenance, issue resolution, version control, and configuration management- Software risk analysis and failure and effect analysis (FMEA)- Cybersecurity processes, risk management, and pre/post-market documentation- Software usability studies.